Kornimate/medical-research-clean huggingface dataset:
corneal collagen cross-linking for progressive keratoconus

Conditions: Progressive Keratoconus

Summary: prospective, randomized multicenter study to determine the safety and effectiveness of performing cornea collagen cross-linking (cxl) using riboflavin and uva light in eyes with progressive keratoconus.

this was a sham controlled study for the first three months. patients had one eye designated as the study eye and were randomized to receive one of two study treatments (cxl or sham) in their study eye. the patients were evaluated at 1, 3, 6, and 12 months. at month 3 or later patients had the option of receiving cxl treatment in both the sham and non-study eye.

Eligibility criteria:
inclusion criteria: * diagnosis of keratoconus * documented progression over previous 24 months * decreased bscva * must complete all study visits exclusion criteria: * prior corneal surgery or intacs * history of delayed wound healing

Keywords: keratoconus cross-linking riboflavin uva light cornea
stimulation tcpo2 test in the pad diagnosis in diabetic foot

Conditions: Peripheral Arterial Disease

Summary: all diagnostic procedures of peripheral arterial disease (pad) in the diabetic foot (df) are limited due to diabetes mellitus and its late complications. the aim of our study is to refine the diagnosis of peripheral arterial disease (pad) by a new transcutaneous oximetry (tcpo2) stimulation test (a modified ratschow test) in patients with diabetic foot.

patients with diabetic foot and mild to moderate pad (wifi - ischemia 1 or 2) with baseline tcpo2 values 30-50 mmhg will be included into the study. tcpo2 will be measured on the feet in different angiosomes. during this measurement a stimulation test consisting of a modified ratschow test involving 2 minutes of exercise will be conducted. specific tcpo2 parameters will be assessed during the whole procedure (resting tcpo2 before stimulation test, minimal tcpo2, delta tcpo2 (minimum tcpo2 minus resting tcpo2) percentage decrease of tcpo2 during the stimulation test and tcpo2 recovery time (time to the adjustment of tcpo2 to the resting values). all tcpo2 parameters detected during tcpo2 stimulation test will be correlated with parameters of macrocirculation (systolic blood pressures (sbp) on tibial arteries and their ankle-brachial indexes (abi), toe pressures (tp) and toe-brachial indexestbi) and dus findings (monophasic/triphasic flow in relevant artery supplying measured angiosome)

Eligibility criteria:
inclusion criteria: * presence of diabetic foot in patients with type 1 or type 2 diabetes mellitus, with wifi classification of ischemia 1-2 (based on tcpo2) without previously diagnosed pad or with known pad based on the patients' history or previous vascular reconstruction (endovascular or surgical vascular interventions) * resting tcpo2 values between 30-50 mm hg. exclusion criteria: * vascular interventions on evaluated limb within 12 months prior to the enrolment into the study * factors possibly influencing for example oxygen saturation or feet movement: * patient imobility * impairment of movements at the talocrural joints * vasculitis * heart failure or advanced copd * severe anaemia (plasma haemoglobin below 8g / dl) * hypoperfusion due to shock or cardiac dysfunction * sepsis * massive swelling of the lower limbs of various ethiology (including lymphedema) * active charcot osteoarthropathy * critical limb ischemia with wifi classification of ischemia 3 * lower limb claudication below 200m * venous insufficiency of ceap classification 6 * severe diabetic kidney disease (ckd stage 4 or 5)

Keywords: diabetic foot peripheral arterial disease tcpo2
high flow nasal cannula versus non invasive positive pressure ventilation in reducing the rate of reintubation

Conditions: Respiratory Failure; Re-intubation Rate

Summary: this is study aim to compare between high flow nasal canula (hfnc) and non invasive positive pressure ventilation (nippv) in reducing the rate of reintubation in mechanically ventilated patient with successful weaning

* high-flow nasal cannula (hfnc) oxygen therapy comprises an air/oxygen blender, an active humidifier, a single heated circuit, and a nasal cannula. it delivers adequately heated and humidified medical gas at up to 60 l/min of flow and is considered to have a number of physiological effects: reduction of anatomical dead space, positive end expiratory pressure ( peep ) effect, constant fraction of inspired oxygen, and good humidification * noninvasive positive-pressure ventilation is a safe and effective means of improving gas exchange in patients with many types of acute respiratory failure . for example, adding noninvasive ventilation to standard therapy decreased the need for endotracheal intubation...for patients assigned to noninvasive ventilation, the ventilator was connected with conventional tubing to a clear, full-face mask with an inflatable soft-cushion seal and a disposable foam spacer to reduce dead space .after the mask had been secured, pressure support was increased to achieve an exhaled tidal volume of 8 to 10 ml per kilogram, a respiratory rate of fewer than 25 breaths per minute, the disappearance of accessory muscle activity (as evaluated by palpation of the sternocleidomastoid muscle), and patient comfort * the effects of high-flow nasal cannula (hfnc) on adult patients with acute respiratory failure (arf) are controversial. the investigators aimed to further determine the effectiveness of hfnc in reducing the rate of endotracheal intubation in adult patients with arf by comparison to noninvasive positive pressure ventilation (nippv)

Eligibility criteria:
inclusion criteria: * all patient suffer from acute respiratory failure and intubated for mechanical ventilation and then extubated for weaning * age \>18 years old exclusion criteria: * in patients less than 18 years old * any contradiction in using hfnc as trauma or surgery or obstruction of nasopharynx * any contradiction in using nippv as facial trauma ..surgery ..deformity..or upper airway obstruction or upper gastrointestinal bleeding or high risk of aspiration
durvalumab and tremelimumab for pediatric malignancies

Conditions: Pediatric Cancer; Solid Tumor Pediatric; Hematological Malignancies

Summary: the purpose of the study is to determine the recommended dose of durvalumab and tremelimumab (immunotherapy drugs) in pediatric patients with advanced solid and hematological cancers and expand in a second phase to test the efficacy of these drugs once this dose is determined.

this is a first time in pediatrics study primarily designed to evaluate the safety and tolerability of durvalumab and durvalumab in combination with tremelimumab at increasing doses in pediatric patients with advanced solid malignancies and hematological malignancies (including lymphomas) and for whom no standard of care treatments exist. although treatment efficacy is not a primary objective of this study given its early phase nature, the patients screened for this study have no curative options and this study offers the potential of some benefit. the study will also characterize the pk of durvalumab and durvalumab in combination with tremelimumab in children and adolescents and explore potential biological activity and immunogenicity by assessing pharmacodynamics, anti drug antibody (ada) levels, and anti-tumor activity. the results from this trial will form the basis for decisions for potential future pediatric studies

Eligibility criteria:
inclusion criteria: * max age =17 years * solid tumors (except primary central nervous system malignant tumors): patients must have a histopathologic confirmation of malignancy. patients must have progressed or are refractory to standard therapies, and for whom no standard of care treatments exist * non-hodgkin's lymphoma, limited to primary mediastinal b-cell lymphoma and anaplastic large cell lymphoma. patients must have progressed or are refractory to standard therapies, and for whom no standard of care treatments exist. * provision of diagnostic tumor sample mandated if available * evaluable disease * no prior exposure to immune-mediated therapy * adequate organ and marrow function * life expectancy of at least 3 months exclusion criteria: * history of allogeneic organ transplantation (exceptions may be allowed for nhl after discussion with sponsor). history of autologous bone marrow transplant may be allowed (after discussion with sponsor). * active or prior documented autoimmune or inflammatory disorders (exceptions) * uncontrolled intercurrent illness * history of primary immunodeficiency * active infection including tuberculosis, hepatitis b, c or hiv * any unresolved toxicity nci ctcae version 5.0 grade ≥2 from previous anticancer therapy (exceptions)

Keywords: pediatric, solid tumors, hematological malignancies, durvalumab, tremelimumab, immunotherapy
xg005 for pain control in subjects undergoing bunionectomy

Conditions: Acute Pain

Summary: this study will evaluate the safety, efficacy, and pk of low dose (750 mg) and high-dose (1250 mg) xg005 oral tablets compared with placebo in subjects undergoing bunionectomy. subjects will be confined in the clinic from check-in through 72 hours post-surgery to monitor subject safety.

this is a multi-center, randomized, double-blind, parallel-group, placebo-controlled study. eligible subjects will be randomized in a 1:1:1 ratio to receive either 750 mg xg005, 1250 mg xg005, or placebo, twice a day, post bunionectomy surgery in domiciled clinic. subjects and all study staff performing study assessments will be blinded to treatment allocation. subjects will be discharged at a reasonable hour of the day after the end of the 72-hour treatment period.there will be a follow-up visit on day 15.

Eligibility criteria:
main inclusion criteria: * scheduled to undergo unilateral first metatarsal bunionectomy * have negative urine drug screen * non-pregnant, non-lactating main exclusion criteria: * medical condition or history that in the investigator's opinion could adversely impact the subject's participation or safety * use of disallowed medications (e.g. pain medication, cns active drugs such as benzodiazepines, tricyclic antidepressants, serotonin, and norepinephrine reuptake inhibitors (snris), selective serotonin reuptake inhibitors (ssris), or any other serotonergic medications, parenteral or oral corticosteroids) * antihypertensive agent or diabetic regimen at a dose that has not been stable for at least 30 days * digoxin, warfarin lithium, theophylline preparations, aminoglycosides, and all antiarrhythmics * monoamine oxidase inhibitors (maois) * positive hbsag and/or anti-hbc but negative anti-hbs * hiv infection * history of illicit drug use * history of opioid dependence * history of nsaid-induced bronchospasm or presence of nasal polyps, history of asthma or chronic rhinitis * significant history of allergic reactions or known intolerance to naproxen, pregabalin or any gabapentinoid, or to any rescue medication used in the study, or any medication used in the surgical and anesthetic protocol. * presence of severe depression as indicated by patient health questionnaire (phq 9) total score of ≥20 or item 9 score \>0 * presence of severe anxiety as indicated by general anxiety disorder (gad-7) score of ≥15 * presence of history of suicidal behavior or ideation as indicated by the c-ssrs
a study to assess the efficacy of xen-d0501 in reducing the cough frequency in patients with chronic idiopathic cough

Conditions: Chronic Idiopathic Cough

Summary: the purpose of this study is to determine the effectiveness of xen-d0501 over placebo in reducing the daytime cough frequency in patients with chronic idiopathic cough. the effectiveness of xen-d0501 over placebo in reducing capsaicin cough responses, objective 24-hour cough frequency, hourly change in cough frequency, cough severity (via visual analogue scale \[vas\]), urge to cough (via vas), global rating of change scale and leicester cough questionnaire (lcq) will be evaluated.


Eligibility criteria:
inclusion criteria: * male/female subjects aged 18 or over with chronic idiopathic cough exclusion criteria: * clinically significant medical history * abnormal laboratory results, ecgs or vital signs
early detection of picc-related deep vein thrombosis by us surveillance: an effective approach for secondary prevention?

Conditions: Central Venous Catheter Thrombosis

Summary: background: picc-related thrombosis have shown a slightly different pattern of frequency and risk factors, compared with traditional cvc; because of the increasing diffusion of piccs, they are becoming a somehow independent pathology, still under investigation; no pharmacological prevention has proved to be effective. aim of this study is to estimate the cumulative incidence of thrombosis in a cohort of patients carrying a picc-line cvc, monitored to allow an early detection and prevention of complications related to the presence of asymptomatic deep venous thrombosis, and to explore the role of several potential risk factors. methods: in a prospective observational cohort we will enroll 150 consecutive patients having a picc inserted by our team; clinical characteristics, comorbidities and main features of catheter positioning procedure will be registered; patients will be followed with clinical and echographic scheduled controls, weekly for the first month, then monthly; patients with prdvt will be treated with lmwh and recontrolled weekly until removal of catheter

all piccs are positioned by trained physicians and nurses, after ultrasonographic screening of the whole upper limbs venous district, axillary, subclavian and jugular veins for detecting possible pre-existing thrombosis; positioning is performed with real-time ultrasonography guide with a portable device. patients are recontrolled one week after positioning; patients who report pain, swelling, fever, skin colour changes, exit site tenderness, or any symptom suspected for thrombosis or infection, are immediately seen. a duplex ultrasound complete examination of the upper limb and neck vessels is performed, and at the same time the whole arm and the exit site is inspected to exclude infections; diagnostic criteria for dvt include incompressibility of the vein and direct visualisation of picc-surrounding thrombus; in uncertain cases, a doppler examination is performed.if the examination is negative for thrombosis, further controls are performed at 2,3,4 weeks after positioning, then once a month.if a dvt is detected, we register the position and extension of the thrombus, and its main characteristics (clot, mural or occlusive thrombosis); the catheter is left in place and a therapy is prescribed with lmwh at full doses, according with accp guidelines 2008 (confirmed in 2012 edition). then, the patient is recontrolled weekly until removal of the catheter.

Eligibility criteria:
inclusion criteria: * all patients undergoing a picc-line positioning during a five-months period exclusion criteria: * age\<18,complete paresis of the arm, history of previous dvt in the same arm, expected very short picc indwelling time (less than 1 week).

Keywords: central venous catheters thrombosis secondary prevention
combined effect of foam roller and gastrocnemius release on plantar fasciitis

Conditions: Plantar Fascitis

Summary: this study will be conducted to investigate the efficacy of combining foam roller and gastrocnemius release on pain intensity level, dorsi flexion range of motion of ankle joint ,dorsi flexion range of motion of big toe and foot function in subjects with plantar fasciitis.

plantar fasciitis refers to degeneration and inflammation of the proximal plantar fascia. the condition presents with plantar medial heel pain, often exacerbated following periods of inactivity, such as upon waking in the morning.the term "plantar fasciitis" has been quoted for years, but this is a misnomer as inflammatory cells are not present in biopsies from involved fascia. therefore, advocate the terminology "plantar fasciitis" to explain the syndrome characterized by pain along the proximal plantar fascia and its attachment in the area of the calcaneal tuberosity with function impairment, implying a more chronic degenerative process than acute heel pain.research found that both stretching and foam rolling techniques helped reduce pain and increase the rom. however, the effectiveness of foam rolling was superior to stretching in terms of increased pressure pain thresholds (ppts) at gastrocnemius and soleus. there was a gap in the previous literature in combined effect of gastrocnemius release and foam roller in managing plantar fasciitis and assessing dorsi flexion range of motion of both big toe and ankle joint along with pain assessment and foot function. sixty patients with planter fascitis will be assigned randomly to two groups; first one will receive manual and foam roller release of gastrocnemius and conventional treatment and the other one will receive conventional treatment only.

Eligibility criteria:
inclusion criteria: * aged between 18 years and 60 years * heel pain in the morning with first step, insidious sharp pain under the heel, tenderness on medial calcaneus and symptoms decreasing with slight activity (like walking) and worsening toward the end of the day exclusion criteria: * infective conditions of foot, tumor, calcaneal fracture * metal implant around ankle * dermatitis, acute sepsis and anesthetic areas * subject with impaired circulation to lower extremities * subject with referred pain due to sciatica * corticosteroids * injection in heel preceding 3 month * patient who cannot co-operate * history of flat foot

Keywords: foam roller gastrocnemius release plantar fascitis
impact of early enteral vs. parenteral nutrition on mortality in patients requiring mechanical ventilation and catecholamines

Conditions: Acute Respiratory Failure; Shock

Summary: the purpose of this study is to assess the hypothesis that, as compared to early intravenous feeding, early nutrition via the enteral route is associated with reduced day 28-mortality in critically ill patients treated with mechanical ventilation and vasoactive drug.


Eligibility criteria:
inclusion criteria: * invasive mechanical ventilation expected to be required more than 48 hours * nutrition started within 24 hours after initiation of endotracheal mechanical ventilation * treatment with vasoactive drug administered via a central venous catheter * age over 18 years * signed information exclusion criteria: * abdominal surgery within 1 month before inclusion * history of esophageal, gastric, duodenal or pancreatic surgery * bleeding from the esophagus, stomach or bowel * enteral nutrition via gastrostomy or jejunostomy * pregnancy * treatment-limitation decisions * current inclusion in a trial on comparison between enteral and parenteral nutrition

Keywords: mechanical ventilation early enteral nutrition intensive care unit early parenteral nutrition critical care medicine nosocomial infection mortality shock vasoactive drug
the effectiveness of the lcp in improving end of life care for dying cancer patients in hospital.

Conditions: Cancer

Summary: the purpose of this study is to evaluate the effectiveness of the lcp-i program in improving the quality of end-of-life care provided to cancer patients who die on hospital medical wards as compared to standard healthcare practices.

the availability of an effective quality improvement program for the care of dying patients in hospitals is particularly relevant to the healthcare scenario. the lcp-i program has provided enough evidence to justify a randomized trial to evaluate its effectiveness. although the core objective of the lcp-i is improving the quality of end of life care for dying patients, the program targets the healthcare professionals working on the hospital ward. the only feasible method of assessing the effectiveness of this program is by performing a cluster trial, where hospital wards are randomized to receive (or not to receive) the implementation of the lcp-i program. pairs of eligible medical wards from different hospitals will be randomized to receive the experimental intervention (the lcp-i program) or no intervention at all for the duration of the study. the lcp-i program will be implemented in the experimental ward by the pcu. the lcp-i program has a duration of 6 months from the beginning of the intensive training. no intervention will be implemented in the control ward until the end of the evaluation. quality of end-of-life care will be evaluated for each pair of randomized wards for all eligible cancer deaths occurring in the six months after the conclusion of the lcp-i program in the experimental ward.

Eligibility criteria:
ward level inclusion criteria: * "medical", "general medical" or "internal medical" ward; * at least 25 cancer deaths on the ward per year; * consent from the hospital and ward management to participate to the trial; * consent from an expert and skills-trained pcu to implement the lcp-i program exclusion criteria: - in the hospital another medical ward has already been randomised. individual level inclusion criteria: - all cancer patients deceased in the ward during the evaluation period; exclusion criteria: - the deceased was a relative of a professional working in the hospital.

Keywords: dying patients cancer hospital liverpool care pathways
aza combined with rchop in p53-mutated dlbcl.

Conditions: DLBCL - Diffuse Large B Cell Lymphoma; TP53

Summary: to evaluate the efficacy and adverse effects of azacitidine in combination with r-chop (archop) for the treatment of tp53-mutated previously untreated diffuse large b-cell lymphoma

this is a phase 2, open-label clinical trial study that aims to evaluate the efficacy (eg. complete response, overall survival, progression free survival) and adverse effects of azacitidine in combination with r-chop (archop) for the treatment of tp53-mutated previously untreated diffuse large b-cell lymphoma

Eligibility criteria:
inclusion criteria: (1)18-70 years old; 2) new-onset tp53 mutant dlbcl; 3) ecog 0-2; 4) lvef \>45%; 5) hbv-positive serology (occult carriers: anti-hbeag +, hbsag-, anti-hbsag +/-) only if hbv-dna test is negative before enrollment; (6) liver function: serum bilirubin ≤ 2.0 × uln, serum alt and ast ≤ 2.5 × uln. renal function: serum cr ≤ 2.0 × uln; (unless due to lymphoma); 7) life expectancy ≥ 6 months; 8) informed consent. exclusion criteria: 1. primary and secondary central dlbcl; 2. hiv-positive patients and or hcv active infection; (3) clinically significant secondary cardiovascular disease; 4) combined hypoxemia severe chronic obstructive pulmonary disease; 5) active bacterial, fungal, and, or viral infections not controlled by systemic therapy; 6) apart from cured basal cell carcinoma of the skin or cervical cancer in situ or early prostate cancer not requiring systemic therapy or early breast cancer requiring only surgery alone. within the last 3 years or concurrently with other malignant tumors; 7) known hypersensitivity or allergic reaction to antibodies or proteins of the murine family
navigation system for in vivo measurement of the kinematics of the knee

Conditions: Knee Osteoarthritis

Summary: the knee prosthesis is a validated treatment for end-stage osteoarthritis, and this intervention usually provides a significant improvement in the quality of life of patients. however, a significant percentage of patients (up 30%) say disappointed with the outcome of the intervention. one hypothesis that could explain these poor results might be poor adaptation of the implants to the patient's anatomy, resulting in a non-physiological kinematics for the patient. multiple studies try to obtain an individual adaptation of the intervention according to multiple criteria. the measurement of the kinematics of the knee before surgery could participate in this process.


Eligibility criteria:
inclusion criteria: * patients over 18 years * patients operated in the service in 2014 to care for end-stage knee osteoarthritis by implantation of a total hip knee prosthesis. exclusion criteria: * patients under 18 years

Keywords: knee knee osteoarthritis knee replacement